Cleaning device for surgical tool

ABSTRACT

The present disclosure relates to a cleaning device system for a surgical tool. Particularly, the present disclosure relates to a novel and advantageous cleaning device system for a laparoscope. The cleaning device system includes a cleaning device, a module, and a control pad. The cleaning device includes a shaft and a nozzle for directing irrigation fluid and drying fluid towards an end of the surgical tool. The module may be a self-contained unit holding saline for cleaning, CO2 for drying, and a battery for powering the system. The cleaning device may be a retrofit device for an existing laparoscope or may be incorporated into a new laparoscope.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation of U.S. application Ser. No.17/089,676, filed Nov. 4, 2020, which claims the benefit of U.S.Provisional Application No. 62/929,955 filed Nov. 4, 2019, the contentsof which are hereby fully incorporated herein by reference.

FIELD OF THE INVENTION

The present disclosure relates to a cleaning device system for asurgical tool. Particularly, the present disclosure relates to a noveland advantageous cleaning device system for a laparoscope. The cleaningdevice system includes a cleaning device, a module, and a control pad.The cleaning device includes a shaft and a nozzle for directingirrigation fluid and drying fluid towards an end of the surgical tool.The module may be a self-contained unit holding saline for cleaning, CO₂for drying, and a battery for powering the system. The cleaning devicemay be a retrofit device for an existing laparoscope or may beincorporated into a new laparoscope.

BACKGROUND OF THE INVENTION

The background description provided herein is for the purpose ofgenerally presenting the context of the disclosure. Work of thepresently named inventors, to the extent it is described in thisbackground section, as well as aspects of the description that may nototherwise qualify as prior art at the time of filing, are neitherexpressly nor impliedly admitted as prior art against the presentdisclosure.

Laparoscope use provides a means for visual guidance during proceduresthat is low-risk and minimally invasive. During a procedure it is commonfor the laparoscope lens to become occluded with various bodily fluidssuch as fatty fluids and blood, as well as by fog. Presently, the commonprocedure used to clean the lens requires removing the lens from thebody, resulting in procedural delay and increased opportunity forinfection. An average procedure requires a lens cleaning rate ofapproximately 6 cleaning events per hour.

Thus, there is a need in the art for a device for cleaning a laparoscopelens, and other in vivo lenses, that does not require removal of thelens from the body.

BRIEF SUMMARY OF THE INVENTION

The following presents a simplified summary of one or more embodimentsof the present disclosure in order to provide a basic understanding ofsuch embodiments. This summary is not an extensive overview of allcontemplated embodiments, and is intended to neither identify key orcritical elements of all embodiments, nor delineate the scope of any orall embodiments.

The present disclosure relates to a cleaning device for a surgical tool.Particularly, the present disclosure relates to a novel and advantageousself-contained cleaning device system for in vivo cleaning of a lens ofa surgical tool, such as a laparoscope. The cleaning device system maybe used to a retrofit an existing surgical tool or may be incorporatedinto a new surgical tool.

The cleaning device system may be provided as a laparoscope accessorythat may be used during surgical procedures, such as in the abdomen. Thesystem may be self-contained without requiring wiring or hook up tooperating room resources. More specifically, the cleaning device systemmay be a self-contained, battery powered self-cleaning retrofit kit,including built-in heating, irrigation, and jet dry or suction systems.The system allows for lens cleaning without requiring removal of thelaparoscope lens from the body, thus improving procedure time andworkflow. In some embodiments, the cleaning device fits onto alaparoscope and provides a flow of fluid across the laparoscope lens.

The present disclosure, in one or more embodiments, additionally relatesto a cleaning device system for use with a surgical device having ashaft and a lens at a distal end of the shaft is provided for cleaningthe lens. The cleaning device system may be a self-contained, batterypowered self-cleaning retrofit kit, including built-in heating,irrigation, and drying systems. In one embodiment, the cleaning devicesystem comprises a cleaning device, a module, and a control pad. Thecontrol pad may be provided as part of the cleaning device or separatefrom and operatively connected to the cleaning device. The cleaningdevice comprises a sheath and a nozzle. The sheath is configured forfitting over the shaft of the surgical device and has an irrigationchannel, a drying channel, and a heating channel. The heating channel isdisposed proximate the irrigation channel and may be used to warm afirst fluid. The nozzle is coupled to a distal end of the sheath. Thenozzle has an irrigation port and a drying port, the irrigation channelterminating at the irrigation port and the drying channel terminating atthe drying port. The module houses an irrigation fluid reservoir, a gascanister, and a power source. A first fluid is dispensed from theirrigation fluid reservoir in the module through the irrigation channelin the sheath and out the irrigation port in the nozzle. A second fluidis dispensed from the gas canister in the module through the dryingchannel in the shaft and out the drying port in the nozzle. The controlpad may have a first button and a second button, wherein the firstbutton runs a cleaning cycle including dispensing the first fluid andthe second button runs a drying cycle including dispensing the secondfluid. In some embodiments, the cleaning cycle may further comprisedispensing the second fluid.

In a further embodiment, a cleaning device system for use with asurgical device having a shaft and a lens at a distal end of the shaftis provided for cleaning the lens using a non-tactile mechanism foractivating a cleaning cycle. The cleaning device comprises a shaft, anozzle, a module, and a non-tactile mechanism for activating a cleaningcycle. The sheath is configured for fitting over the shaft of thesurgical device and has an irrigation channel and a drying channel. Thenozzle is coupled to a distal end of the sheath. The nozzle has anirrigation port and a drying port, the irrigation channel terminating atthe irrigation port and the drying channel terminating at the dryingport. The module houses an irrigation fluid reservoir, a gas canister,and a power source. A first fluid is dispensed from the irrigation fluidreservoir in the module through the irrigation channel in the sheath andout the irrigation port in the nozzle. A second fluid is dispensed fromthe gas canister in the module through the drying channel in the shaftand out the drying port in the nozzle. In some embodiments, thenon-tactile mechanism may be autonomous. Such autonomous mechanism maybe comprise a sensor that senses when the lens is dirty by evaluatingimages from the lens or a sensor that senses when the lens is dirty byevaluating light reflection. In another embodiment, the non-tactilemechanism is voice activation. In some embodiments, the non-tactilemechanism may activate a drying cycle. A further mechanism, tactile ornon-tactile, may also be provided to activate a supplemental cleaningcycle or drying cycle.

A cleaning device system for use with a surgical device having a shaftand a lens at a distal end of the shaft is provided in yet a furtherembodiment. The cleaning device system comprises a cleaning device, amodule, and a control pad. The control pad may be provide as part of thecleaning device or separate from and operatively connected to thecleaning device. The cleaning device may comprise a sheath and a nozzle.The sheath may be for fitting over the shaft of the surgical device, thesheath. The sheath may have an irrigation channel, a drying channel, anda heating channel, wherein the heating channel is disposed proximate theirrigation channel. The nozzle may be coupled to a distal end of thesheath. The nozzle may have an irrigation port and a drying port, theirrigation channel terminating at the irrigation port and the dryingchannel terminating at the drying port. The module may house anirrigation fluid reservoir, a CO₂ canister, and a power source. Theirrigation fluid reservoir may have a volume sufficient for at least tencleanings without refilling. Saline is dispensed from the irrigationfluid reservoir in the module through the irrigation channel in thesheath and out the irrigation port in the nozzle and CO₂ gas isdispensed from the gas canister in the module through the drying channelin the shaft and out the drying port in the nozzle. The saline is heatedto a temperature of at least 104° F. in the irrigation channel. Thecontrol pad may have a first button and a second button, wherein thefirst button runs a cleaning cycle comprising dispensing the saline anddispensing the CO₂ and the second button runs a supplemental dryingcycle comprising dispensing the CO₂.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, thevarious embodiments of the present disclosure are capable ofmodifications in various obvious aspects, all without departing from thespirit and scope of the present disclosure. Accordingly, the drawingsand detailed description are to be regarded as illustrative in natureand not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter that is regarded as formingthe various embodiments of the present disclosure, it is believed thatthe invention will be better understood from the following descriptiontaken in conjunction with the accompanying Figures, in which:

FIG. 1a illustrates a cleaning device mounted on a laparoscope, inaccordance with one embodiment.

FIG. 1b illustrates a cleaning device system, in accordance with anotherembodiment.

FIG. 2a illustrates a cleaning device mounted on a laparoscope, inaccordance with one embodiment.

FIG. 2b illustrates a cleaning device mounted on a laparoscope, inaccordance with another embodiment.

FIG. 2c illustrates a cleaning device mounted on a laparoscope, inaccordance with yet another embodiment.

FIG. 3a illustrates a sheath of a cleaning device as coupled to acontrol pad, in accordance with one embodiment.

FIG. 3b illustrates the control pad of FIG. 3 a.

FIG. 3c illustrates a further view of the control pad of FIG. 3 a.

FIG. 4a illustrates a module/control box, in accordance with oneembodiment.

FIG. 4b illustrates a further view of the a module/control box of FIG. 4a.

FIG. 5a illustrates a top tray of a transportation box, in accordancewith one embodiment.

FIG. 5b illustrates a bottom tray of a transportation box, in accordancewith one embodiment.

FIG. 6a illustrates the module provided separate from the sheath andcontrol pad such that it may be positioned on an operating room table,in accordance with one embodiment.

FIG. 6b illustrates the module provided on the shaft of a laparoscope,in accordance with one embodiment.

FIG. 6c illustrates the module provided separate from the sheath andcontrol pad and configured to be wearable on the wrist of a user, inaccordance with one embodiment.

FIG. 7a illustrates a perspective view of a sheath of a cleaning device,in accordance with one embodiment.

FIGS. 7b illustrate an end view of the sheath of FIG. 7 a.

FIGS. 7c illustrate an end view of the sheath of FIG. 7 a.

FIG. 8a illustrates a perspective view of a sheath of a cleaning device,in accordance with another embodiment

FIG. 8b illustrates an end view of the sheath of FIG. 8 a.

FIG. 9a illustrates an end of a sheath of a cleaning device aspositioned on a laparoscope sheath, in accordance with one embodiment.

FIG. 9b illustrates a nozzle face for attachment to the sheath of acleaning device, in accordance with one embodiment.

FIG. 9c illustrates the nozzle of FIG. 9b as attached to the sheath of acleaning device positioned on a laparoscope sheath, in accordance withone embodiment.

FIG. 9d illustrates the nozzle of FIG. 9b as attached to the sheath of acleaning device positioned on a laparoscope sheath, in accordance withone embodiment.

FIG. 10a illustrates an initial optional step in setting up the cleaningdevice system, in accordance with one embodiment.

FIG. 10b illustrates an initial optional step in setting up the cleaningdevice system, in accordance with one embodiment.

FIG. 11 a illustrates insertion of a laparoscope shaft into the sheathof a cleaning device, in accordance with one embodiment.

FIG. 11b illustrates insertion of a laparoscope shaft into the sheath ofa cleaning device, in accordance with one embodiment.

FIG. 11c illustrates a sheath attached to a retaining feature and theretaining feature attached to a laparoscope at the light post of thelaparoscope, in accordance with one embodiment.

FIG. 12a illustrates connection of tube connectors to ports and anelectrical cable to an electrical port, in accordance with oneembodiment.

FIG. 12b illustrates connection of tube connectors to ports and anelectrical cable to an electrical port, in accordance with oneembodiment.

FIG. 12c illustrates connection of tube connectors to ports and anelectrical cable to an electrical port, in accordance with oneembodiment.

FIG. 13 illustrates removal of a fill syringe tube from a fill port, inaccordance with one embodiment.

FIG. 14a illustrates review of pressure after filling a reservoir, inaccordance with one embodiment.

FIG. 14b illustrates review of pressure after filling a reservoir, inaccordance with one embodiment.

FIG. 15a illustrates installation of a CO₂ canister or cartridge, inaccordance with one embodiment.

FIG. 15b illustrates installation of a CO₂ canister or cartridge, inaccordance with one embodiment.

FIG. 16a illustrate an extruded plastic sheath having an injectionmolded tip with a nozzle attached to the sheath tip, in accordance withone embodiment.

FIG. 16b illustrate an extruded plastic sheath having an injectionmolded tip with a nozzle attached to the sheath tip, in accordance withone embodiment.

FIG. 16c illustrates an end view of the injection molded tip of FIG. 16a.

FIG. 16d illustrates a rear view of a nozzle of a cleaning device, inaccordance with on embodiment

FIG. 17a illustrates a distal end of a welded stainless steel sheath ofa cleaning device and a nozzle of a cleaning device, in accordance withone embodiment.

FIG. 17b illustrates a distal end of a welded stainless steel sheath ofa cleaning device and a nozzle of a cleaning device, in accordance withone embodiment.

FIG. 17c illustrates a distal end of a welded stainless steel sheath ofa cleaning device and a nozzle of a cleaning device, in accordance withone embodiment.

FIG. 17d illustrates a distal end of a welded stainless steel sheath ofa cleaning device and a nozzle of a cleaning device, in accordance withone embodiment.

FIG. 18a illustrates various aspects of a cleaning device for use with alaparoscope, in accordance with one embodiment.

FIG. 18b illustrates various aspects of a cleaning device for use with alaparoscope, in accordance with one embodiment.

FIG. 18c illustrates various aspects of a cleaning device for use with alaparoscope, in accordance with one embodiment.

FIG. 18d illustrates various aspects of a cleaning device for use with alaparoscope, in accordance with one embodiment.

FIG. 18e illustrates various aspects of a cleaning device for use with alaparoscope, in accordance with one embodiment.

FIG. 18f illustrates various aspects of a cleaning device for use with alaparoscope, in accordance with one embodiment.

FIG. 19a illustrates a sheath of a cleaning device, in accordance withanother embodiment.

FIG. 19b illustrates the sheath of FIG. 19 a.

FIG. 19c illustrates the sheath of FIG. 19 a.

FIG. 20a illustrates attachment of a sheath, in accordance with oneembodiment.

FIG. 20b illustrates attachment of a sheath, in accordance with oneembodiment.

FIG. 20c illustrates attachment of a sheath, in accordance with oneembodiment.

FIG. 20d illustrates attachment of a sheath, in accordance with oneembodiment.

FIG. 21a illustrates a schematic for an embodiment of a cleaning deviceusing jet drying.

FIG. 21b illustrates a layout for an embodiment of a cleaning deviceusing jet drying.

FIG. 22a illustrates a schematic for an embodiment of a cleaning deviceusing vacuum drying.

FIG. 22b illustrates a layout for an embodiment of a cleaning deviceusing vacuum drying.

FIG. 23a illustrates a schematic for a cleaning device using jet drying,in accordance with another embodiment.

FIG. 23b illustrates a layout a cleaning device using jet drying, inaccordance with another embodiment.

FIG. 24a illustrates a schematic for a cleaning device using vacuumdrying, in accordance with another embodiment.

FIG. 24b illustrates a layout a cleaning device using vacuum drying, inaccordance with another embodiment.

FIG. 25a illustrates a schematic for a cleaning device using vacuumdrying, in accordance with a further embodiment.

FIG. 25b illustrates a layout a cleaning device using vacuum drying, inaccordance with a further embodiment.

FIG. 26a illustrates a schematic for a cleaning device using operatingsupplied suction, in accordance with one embodiment.

FIG. 26b illustrates a layout a cleaning device using operating suppliedsuction, in accordance with one embodiment.

FIG. 27a illustrates a schematic for a cleaning device using operatingsupplied suction, in accordance with another embodiment.

FIG. 27b illustrates a layout a cleaning device using operating suppliedsuction, in accordance with another embodiment.

FIG. 28a illustrates a soiled scope.

FIG. 28b illustrates the scope of FIG. 28a after an initial wash at 5psi irrigation and 40 psi jet-dry using an embodiment of a cleaningdevice as described herein.

FIG. 29a illustrates a pre-soiled scope.

FIG. 29b illustrates the scope of FIG. 29a in a soiled condition.

FIG. 29c illustrates the scope of FIG. 29c after cleaning using anembodiment of a cleaning device as described herein.

DETAILED DESCRIPTION

The present disclosure relates to a cleaning device system for asurgical tool. Particularly, the present disclosure relates to a noveland advantageous cleaning device system for a laparoscope. The cleaningdevice system includes a cleaning device, a module, and a control pad.The cleaning device includes a shaft and a nozzle for directingirrigation fluid and drying fluid towards an end of the surgical tool.The module may be a self-contained unit holding saline for cleaning, CO₂for drying, and a battery for powering the system. The cleaning devicemay be a retrofit device for an existing laparoscope or may beincorporated into a new laparoscope or similar device. For example, insome embodiments, an inventive laparoscope or other scope may includeone or more of the design elements of the present invention in a mannerthat is integrated within the shaft of the scope, and such that noadditional accessories are required to utilize the functionalitydescribed herein.

The cleaning device system may be provided as a laparoscope accessorythat may be used during surgical procedures, such as in the abdomen. Thesystem may be self-contained without requiring wiring or hook up tooperating room resources. More specifically, the cleaning device systemmay be a self-contained, battery powered self-cleaning retrofit kit,including built-in heating, irrigation, and jet dry or suction systems.The system allows for lens cleaning without requiring removal of thelaparoscope lens from the body, thus improving procedure time andworkflow. In some embodiments, the cleaning device fits onto alaparoscope and provides a flow of fluid across the laparoscope lens.The volume of fluid remaining in the body may be kept low in order toensure absorption following the procedure.

In general, the cleaning device may be used with any surgical instrumentthat is used in vivo and includes a shaft with an end that requirescleaning. The cleaning device system may be used to clear, for example,fatty fluids, blood, and fog from a lens of a surgical device, such as alaparoscope, while the surgical device is in vivo.

In one embodiment, the cleaning device fits onto a laparoscope and worksby providing a controlled flow of a first fluid, such as water orsaline, across the lens followed by a blast of CO₂ or other fluid to aidin clearing loosed debris and the first fluid and to dry the lens. Thefirst fluid, e.g. water or saline, the second fluid, e.g. CO₂, andpower, e.g. a battery, may be provided in the cleaning device systemsuch that no hook up to operating room resources is necessary. Thevolume of fluid remaining in the body after cleaning may be minimized tofacilitate absorption following the procedure.

It is to be appreciated that the cleaning device may alternatively bedesigned to attach to surgical robots or other devices by customizingdimensions of a sheath of the cleaning device, and work to clean suchlenses of any in vivo device in substantially the same manner asdescribed herein with respect to laparoscopes. The cleaning device maybe configured to facilitate articulation such that it may be used withsurgical devices that articulate. Further, the cleaning device may beconfigured to be flexible (such as having a flexible sheath) for usewith endoscopy type systems.

In some embodiments, the system may be configured for abdominalinsufflation. This comprises pumping a gas, for example CO₂, into theperitoneal cavity producing a pneumoperitoneum to cause an increase inintra-abdominal pressure (TAP). In order to perform such insufflation,the cleaning device may be activated to dispense only CO₂, withoutirrigating. For insufflation, a sheath having a drying tube sized forappropriate CO₂ flow and a nozzle configured to direct CO₂ outwardlyfrom the device. Carbon dioxide may insufflated into the peritonealcavity at a rate of 4-6 liter min⁻¹ to a pressure of 10-20 mm Hg.

FIGS. 1a and 1b illustrate embodiments of a cleaning device system. FIG.1a illustrates the cleaning device system 10 with a cleaning device 12thereof mounted to a laparoscope 5. FIG. 1b illustrates the cleaningdevice system unassociated with a surgical device. As shown, thecleaning device system 10 may include a cleaning device 12 and a moduleor control box 18. The cleaning device 12 comprises a sheath (alsoreferred to as a shaft) 14, a nozzle 15, a control pad 16, and aretaining feature 20. In the embodiment shown in FIGS. 1a and 1 b, themodule 18 carries a reservoir for holding fluid for cleaning the lensand receives a CO₂ canister or cartridge for drying the lens. While aCO₂ canister is discussed herein, any suitable material or method forjet drying may be used in such embodiments. The module 18 may furtherinclude a battery for powering the cleaning device system. As shown inFIG. 1 b, tubing 17 may extend between the cleaning device 12 and themodule 18 to feed first and second fluids, such as saline and CO₂, fromthe module 18 to the cleaning device 12. Cable 19 runs from the module18 to the control pad 16 to power the control pad 16. A transportationbox (shown in FIGS. 5a and 5b ) may also be provided.

As shown in FIG. 1 a, the cleaning device 12 may be mounted to anexisting laparoscope such that, as deployed, the lens of the laparoscopeis exposed and a user may operate the laparoscope to use the laparoscopeas normal and actuate buttons on the control pad of the cleaning deviceto clean the lens of the laparoscope. The control pad may be used todispel a first fluid, such as saline or water, across the lens to removedebris from the lens and blow a second fluid, such as CO₂, across thelens to further remove debris dry the lens. The present disclosurespecifically discusses the cleaning device as used with 10 mm 30 degreelaparoscopes. Such specificity is for illustrative purposes only and isnot intended to be limiting. With specific reference to laparoscopes,the cleaning device may be used with virtually any size of sheath suchas 3 mm, 5 mm, 8 mm, 10 mm diameter and 0 degree, 10 degree, 30 degree,and 45 degree angles. It is to be appreciated that the length anddiameter of the sheath may be customized for the surgical device orsurgical robot with which it is to be used.

The cleaning device system may be used to irrigate and dry the lens atthe end of a surgical device, such as a laparoscope, or a surgicalrobot. In various embodiments, drying may be done by jet-drying or bysuction. In some embodiments, cleaning may be a closed loop. Thecleaning device system may be a self-contained system that carries itsown irrigation fluid, drying mechanism, and battery such that operatingroom water, air, and electricity are not required. In other embodiments,the cleaning device system may have connections to operating room water,air, and/or electricity. Further, when provided as a self-containedsystem, the cleaning device system may nevertheless have back upconnections to operating room water, air, and/or electricity.

In some embodiments, all or part of the cleaning device system may bedisposable. For example, in one embodiment, the sheath and controlpad/grip portions are each disposable, while the control pad and modulemay be reusable. In another embodiment, only the sheath is disposable,while the other elements are reusable. In embodiments utilizing a CO₂canister, the canister may be disposable. Likewise, the reservoir may beeither fully replaceable or reusable. In general, it may be useful forat least heater elements and electronics to be reusable. In alternativeembodiments, the cleaning device system may be fully disposable.

FIGS. 2a, 2b, and 2c illustrate various embodiments of a sheath 14 andnozzle 15 of a cleaning device mounted on a laparoscope 5 in accordancewith other embodiments. The sheath may have a retaining feature 20 forrestraining the sheath 14 on the surgical device. FIG. 2b furtherillustrates the shaft tube set receptors 21 for receiving tubing fromthe module. In the embodiment of FIG. 2c , the sheath 14 is c-shaped andhas an open channel 24 along an upper surface.

FIG. 2c further illustrates one embodiment of a nozzle 15. The nozzle isprovided at the distal end of the sheath and may connect to a tip of thesheath. The nozzle may be configured to direct irrigation fluid and CO₂(or other fluid or suction) towards the lens.

FIG. 3a illustrates the sheath 14 of a cleaning device as coupled to thecontrol pad 16. FIGS. 3b and 3c illustrate the control pad 16, inaccordance with various embodiments. The control pad may include aconnection interface for connecting to the laparoscope distal to thelight port of the laparoscope. As shown, the control pad includesinterface controls—a first button 30 and a second button 32. The buttonsmay be provided, for example, on a two button membrane switch. The firstbutton 30 may be referred to as an irrigation button and the secondbutton 32 may be referred to as a drying button. The irrigation button30 actuates an irrigation valve and the drying button 32 actuates adrying valve. In some embodiments, the first button 30 may actuate boththe irrigation valve and the drying valve, thus launching a cleaningcycle, and the drying button 32 may have a supplemental drying function.In such embodiment, the irrigation button may be referred to as a cyclebutton, activating both flushing and drying functions. If the lens isnot sufficiently dry after actuation of the cycle button 30, the dryingbutton 32 may be actuated to trigger further drying.

The control pad is communicatively coupled to the module such thatactuation of buttons on the control pad actuate valves in the module.For example, a cable may be provided between the control pad and themodule. Alternatively, communication may be done via infrared, radiofrequency, Bluetooth, or other.

The valves in the module may be mechanical valves or electrical valves.The buttons 30, 32 may actuate momentary switches such that the usercontrols the time of irrigation and/or drying. Alternatively, thebuttons 30, 32 may actuate electric switches with a preset run time. Inone embodiment, the valves are electronically controlled comprisingbuttons on the control pad and solenoid valves in the module. In analternative embodiment, the interface controls may be provided on themodule and a control pad may not be provided on the cleaning device.

While specific detail is given regarding one or more buttons being usedto control irrigating and drying, this functionality by be otherwisetriggered. For example, the cleaning device system may be provided withvoice activation for controlling irrigating and drying. In anotherembodiment, cleaning may be automatic. More specifically, the cleaningdevice may detect when the lens of the surgical device is dirty and mayrun itself through one or more cleaning cycles. This may be done, forexample, by using a light sensor and detecting refraction of lightthrough the lens. In some embodiments, white light spectroscopy andsoftware analysis of light reflection may be used to detect whether thelens is dirty. In another automatic embodiment, the cleaning device maydetect that the lens is dirty by looking at the image generated by thecamera and detecting that the image is blurry. In some embodiments, thecleaning device system may have an automatic run cycle capability butalso have supplemental clean cycle or drying functionality via a controlpad.

FIGS. 4a and 4b illustrate a module/control box 18 in accordance withone embodiment. The module 18 encloses a plurality of components of thecleaning device system. In general, the module is protective and has asmall size. The module houses an irrigation fluid reservoir and CO₂canister or cartridge. Each of the fluid reservoir and the CO₂ canistermay be replaceable and/or refillable, including during a surgicalprocedure. The module may further house a battery. Alternatively themodule may be configured to plug into operating room electricity. TheCO₂ may be used to drive operation of each cleaning event, pumping theirrigation fluid and providing for air expulsion or vacuum. The fluidreservoir may be provided as a cartridge having capability of irrigationand waste storage and may be disposable. The CO₂ canister, fluidreservoir cartridge, and battery all may be replaceable mid-procedure asnecessary. That being said, the fluid reservoir and/or the CO₂ canistersmay have sufficient capacity such that it is not necessary to refill thefluid reservoir or replace the CO₂ canister during a procedure. Inalternative embodiments, one or more of the fluid reservoir, CO₂canister, or battery may not be provided in the module.

In one embodiment, the fluid reservoir is refillable and holds a volumesufficient to deliver, for example, between 8 and 20 cleaning cyclesbefore needing to be refilled. In one embodiment, the fluid reservoirholds a volume sufficient to delivery 10 cleaning cycles before needingto be refilled. In one embodiment, the amount of fluid used per cleaningis 1.25 ml and the fluid reservoir holds a minimum of 30 ml of fluidplus an additional volume to accommodate system purge plus tolerance (10ml). The volume of the fluid reservoir may be customized based on theintended use of the cleaning device system. In one embodiment, a 16 gcompressed CO₂ cartridge is provided.

In one embodiment, the module may be sized to accommodate a fluidreservoir, CO₂ canister, and battery capable of between 5 and 20cleanings with the cleanings having irrigation volumes ranging fromabout 0.25 mL to about 0.5 mL (for example, 1.25 or 1.5 mL) andirrigation times ranging from about 1 to about 3 seconds. For example,in one embodiment, the module may be sized to accommodate a fluidreservoir, CO₂ canister, and battery capable of 10 cleanings each havingan irrigation of about 3 seconds. The fluid reservoir may have a sizebetween about 10 mL and about 30 mL. In one embodiment, the amount offluid used per cleaning is 1.25 ml and fluid dispensing is done at aminimum rate of 6 times per hour. The battery may have any suitablecapacity. In one embodiment, the battery may have a 9.18 watt hourcapacity.

FIG. 4a illustrates the module 18 having a CO₂ canister 40 received by aCO₂ port 41, pressure gauge 42, fill port 44, saline port 46, CO₂ port48, and electrical connection port 50. The saline port 46 and CO₂ 48port receive tube connectors 47 and 49 respectively. The tube connectors47 and 49 receive tubing to connect to cleaning device. In alternativeembodiments, the ports 46 and 48 may connect directly to the tubing. Theelectrical connection port 50 receives an electrical cable 51.

FIG. 4b illustrates the module 18 having a prime button 53, thermaladjustment knob 54, programming entry 55 (plugged), power switch 56,power entry 57, and pressure adjustment knob 58.

The module 18 may further house an electronics controller, a momentaryswitch for performing a system purge, a power switch to power on thesystem, and a regulator. The momentary switch for performing a systempurge may be incorporated into a power-up sequence, i.e., the device isplugged in, the power switch is pressed, powering on unit followed by avolume of fluid being dispensed through the system.

FIGS. 5a and 5b illustrate a transportation box 60 for storing thecleaning device system and, optionally, accessories. More specifically,the transportation box may be used to house the device (including shaftand tube set), the module/control box, a filling syringe and tube set,and a USB Type A to USB Type Micro B cable (or other charging cable ormechanism). The transportation box 60 may have two layers, the top layerbeing shown in FIG. 5a and the bottom layer being shown in FIG. 5b . Inone embodiment, the layers are formed by foam trays. The exactconfiguration is meant for illustrative purposes only and thetransportation box may house the cleaning device system in analternative configuration.

In the embodiment of FIG. 5a , the top tray 62 of the transportation box60 holds the module or control box 18, a filling syringe and tube set64, and a microfiber towel and gear ties 66. Storage locations 68 areprovided for a plurality of CO₂ canisters, the canisters being placed onthe lower tray.

In the embodiment of FIG. 5b , the bottom tray 70 stores the cleaningdevice 12, a plurality of CO₂ canisters 72, a power supply and powercord 74, and a USB Type A to USB Type Micro B Cable 76. The plurality ofCO₂ canisters may be, for example, four 16g CO₂ canisters.

In various embodiments, during surgery, the module may be provided onthe surgical tool shaft, on the cleaning device control pad, or separatefrom the cleaning device. FIGS. 6a -6c illustrate the module 18 indifferent positions.

FIG. 6a illustrates the module 18 provided separate from the surgicaltool 5 and cleaning device 12 such that it may be positioned on anoperating room table.

FIG. 6b illustrates the module 18 provided on the shaft of a surgicaltool 5. This embodiment may be useful with, for example, a bariatriclaparoscope or other surgical device having a relatively longer shaftlength.

FIG. 6c illustrates the module 18 provided separate from the surgicaltool 5 and cleaning device 12 and configured to be wearable on the wristof a user.

Returning to FIG. 1 a, the cleaning device system is shown with alaparoscope. The cleaning device 12 is attached to the laparoscope andincludes a sheath 14, a nozzle 15, and a control pad 16. In someembodiments, the shaft comprises a hollow tube structure having twochannels or lumens, one for a first fluid, such as saline, and one for asecond fluid, such as compressed CO₂. These channels may be referred toas an irrigation channel and a drying channel. The shaft structure maybe sized to the dimension of the scope or other surgical tool. It is tobe appreciated that this sizing will vary depending on the surgicaldevice with which the cleaning device is being used. In one embodiment,the shaft may have a tube structure that fits over a Karl Storz scope,P/N 26003 BA (Ø10 mm, 30° tip, 31 mm length) and may be capable oftraversing the ID of an Ethicon XCEL Bladeless Trocar with StabilitySleeve 12 mm-100 mm, P/N B12LT.

The shaft of the cleaning device may be formed of any suitable material.For example, the shaft may be formed of extruded plastic or of weldedstainless steel. The sheath 14 includes a proximal end interfacing withthe control pad 16 and a distal end interfacing with the nozzle 15. Thesheath 14 may have a retaining feature 20 for restraining the shaft ofthe sheath on the surgical device. The sheath may include an irrigationchannel and a drying channel. The sheath may further include a heatingelement channel. In some embodiments more than one irrigation channel,drying channel, or heating element channel may be provided. The sheath14 may be sized to accommodate a laparoscope shaft or shaft of othersurgical device. Thus, for example, if the cleaning device is to be usedwith a 10mm laparoscope shaft, the sheath may have an inner diameter ofabout 10mm and an outer diameter of about 12mm. If the cleaning deviceis to be used with a 5mm laparoscope sheath, the sheath may have aninner diameter of about 5mm and an outer diameter of about 7mm.Accordingly, the thickness of the shaft may be about 2mm. In alternativeembodiments, different inner and outer diameters and differentthicknesses may be used. The shaft may have a lubricious interior,whether by manufacture of a lubricious material or by addition of alubricious coating, to facilitate sliding of the sheath 14 onto a shaftof a surgical tool such as a laparoscope.

In some instances, it may be desirable to warm the irrigation fluid tofacilitate clearing of fatty fluids and fog. For example, it may bedesirable to warm the fluid to a temperature of at least about 40° C.(104° F.). A heating element thus may be provided to heat the fluid toapproximately 40° C. (104° F.). This may be done by heating the fluid inthe shaft or at the reservoir. The heating element may be chosen suchthat it is able to heat the fluid to the desired temperature, forexample 40° C., in 10 minutes or less. In various embodiments, theheating element may be a conformal shaft resistive heater. In oneembodiment, the heating element comprises a resistive heating wireinserted in a resistive wire lumen. Heating may be achieved in an open-or a closed-loop approach (with or without temperature sensing). Theheating element may be provided in a heating element channel of theshaft and powered by the battery in the module. Alternatively, otherheating elements or approaches may be used. For example, in anotherembodiment, the area of the lens, rather than the fluid, may be heated.In such an embodiment, a heated lens may be provided over thelaparoscope lens (ITO coating/film).

The sheath and nozzle of the cleaning device are complementary such thatchannels provided in the sheath engage ports in the nozzle. In oneembodiment, the irrigation channel and the drying channel are opposedfrom one another on opposite sides of the sheath. In another embodiment,the irrigation channel and the drying channel are on the same side ofthe sheath. In one such embodiment, the irrigation direction is downwardand to the right (facing distally) and the jet-dry direction is downwardand to the left (facing distally). The cross-sectional area of theirrigation channel and the drying channel may be the same or may bedifferent. In an embodiment using an irrigation channel and a suctionchannel (as opposed to a drying channel), the irrigation channel mayhave a larger cross-suction than the vacuum channel to provide forhigher velocity.

FIGS. 7a, 7b, and 7c illustrate a sheath 14 of a cleaning device whereinthe irrigation channel and the drying channel are on the same side ofthe sheath, in accordance with exemplary embodiments. FIG. 7aillustrates a perspective view of a sheath 14 of a cleaning device, inaccordance with one embodiment. As shown, the sheath has a thicker upperwall that tapers alongside walls to an open bottom.

FIGS. 7b and 7c illustrate an end views of a sheath 14 such as shown inFIG. 5a , in accordance with two embodiments. The end view shows anirrigation channel or lumen 80 and a drying channel or lumen 82 in anupper wall of the sheath 14. One or heating channels 84 are providedbetween the irrigation channel 80 and the drying channel 82. The heatingchannels 84 may receive resistive wires.

FIGS. 8a and 8b illustrate a variation of the embodiments shown in FIGS.7a -7 c. In the embodiment of FIGS. 8a and 8b , the irrigation channel80 and drying channel 82 are on the same side of the sheath 14. Thesheath 14 has a thicker upper wall that tapers alongside walls to a thinbottom wall.

The nozzle of the cleaning device may have any suitable configurationfor generally directing irrigation fluid, and optionally drying fluid,such as CO₂, towards the lens. In some embodiments, the irrigation fluidand the drying fluid may be directed towards the lens in the samemanner. In other embodiments, the irrigation fluid and the drying fluidmay be directed differently, for example with the irrigation fluid beingdirected at the lens and the drying fluid being directed across thelens.

FIGS. 9a -9d illustrate a nozzle of a cleaning device in accordance withone embodiment. FIG. 9a illustrates an end of a laproscope with a sheath14 of a cleaning device provided around the shaft of the laparoscope 5but without a nozzle attached to the sheath 14 of the cleaning device.FIG. 9a illustrates a 30 degree laparoscope 5. As shown, the sheath 14of the cleaning device may terminate prior to the end of thelaparoscope. In alternative embodiments, the sheath 14 of the cleaningdevice may extend to or past the end of the laparoscope.

FIG. 9b illustrates a nozzle 15 for attachment to the shaft of acleaning device, in accordance with one embodiment. FIGS. 9c and 9dillustrate the nozzle of FIG. 9b as attached to the sheath 14 of acleaning device positioned on a laparoscope 5 shaft, in accordance withone embodiment. In the embodiment shown, the nozzle 14 folds over anupper wall of the laparoscope sheath to direct irrigation fluid and airor CO₂ for jet drying towards the lens of the laparoscope.

Detail will now be given to set up of the cleaning device system, inaccordance with one embodiment.

FIGS. 10a and 10b illustrate an initial optional step after removing thesystem from the transportation box. In some embodiments, a shaft supportelement 100 may be provided in the sheath 14 during storage. An initialstep thus is to remove such shaft support element 100 if provided.

FIGS. 11a and 11b illustrate insertion of a laparoscope shaft into thesheath 14 of the cleaning device and securement of the laparoscope shaftin the sheath 14. FIGS. Ba and Bb illustrate the cleaning device with aKarl Storz scope, P/N 26003 BA (Ø10 mm, 30° tip, 31 mm length). However,the cleaning device may be used with any suitable surgical device orrobot and the scope is show for illustrative purposes only.

FIG. 1 la illustrates insertion of the scope into the sheath 14.Insertion is through the retaining feature 20. The scope is insertedsuch that the light post 7 on the laparoscope abuts or nearly abuts theretaining feature 20. The shaft tube set receptors 21 may be coupled tothe light post 7 using any suitable mechanism. For example, the shafttube set receptors 21 may be coupled to the light post 7 using gearties, as shown in FIG. 11 b.

Accordingly, in order to use the cleaning device, the sheath 14 isattached to the retaining feature 20 (optionally holding the control pad16) and the retaining feature is attached to the laparoscope at thelight post 7 of the laparoscope. FIG. 11c illustrates such connection.

The cleaning device may include a tube set and control cable. In oneembodiment, the tube set and cable are permanently affixed to the shaftand detachable coupled to the module/control box. In alternativeembodiments, either or both of these may be removably coupled to theshaft or permanently affixed to the module/control box. In oneembodiment, the tube set and cable are approximately 1000 mm −0/+50 mmin length.

FIGS. 12a-12c illustrate connection of tube connectors 47, 49 to ports46 and 48 and an electrical cable 51 to the electrical port 50 for anembodiment wherein the tube set is detachably coupled to the module. Thetube connectors 47, 49 and ports 46, 48 may be color coded to ensure thecorrect tube connector 47, 49 is connected to the correct port 46, 48.More specifically, the tube connectors 47, 49 and ports 46, 48 may becolor coded to ensure that the saline 47 connector is connected to thesaline port 46 and the CO₂ (or other fluid) connector 49 is connected tothe CO₂ (or other fluid) port 48.

FIG. 12a illustrates the module 18 prior to connection of the tubeconnectors 47, 49 to the ports 46, 48 but after connection of theelectrical cable 51 to the electrical port 50. FIG. 12b shows theopposite order of connection with the tube connectors 47, 49 coupled toports 46, 48 but before connection of the electrical cable 51 to theelectrical port 50. FIG. 12c illustrates the module 18 with the tubeconnectors 47, 49 coupled to ports 46, 48 and the electrical cable 51coupled to the electrical port 50. In one embodiment, coupling of theelectrical cable comprise aligning a connection piece of the electricalcable 51 with the electrical port 50, pushing the connection piece intothe port 50 to make a connection, and turning the connection piece tolock it in place.

The internal reservoir of the module is filled using a filling syringeand tube set (62 of FIG. 5a ). This may be done, for example, byinserting the tube into the push-to connect fill port 44. In oneembodiment, to fill the reservoir, the power switch must be in the offposition to allow air behind the piston cylinder to vent during the fillprocess. FIG. 13 illustrates removal of the fill syringe tube 63 of thefilling syringe and tube set 62 from the fill port 44. In one embodimentthis may be done by pressing inwardly on a collar 45 surrounding thefill syringe tube and pulling the tube away from the port 44.

FIGS. 14a and 14b illustrate review of pressure after filling thereservoir. The pressure gauge or regulator 42 is inspected to ensurethat the pressure is set to zero pounds per square inch (psi). Thepressure adjustment knob 58 may be used to adjust pressure as necessary.

FIGS. 15a and 15b illustrate installation of a CO₂ canister or cartridge40, in accordance with one embodiment. The CO₂ cartridge 40 may be, forexample, a 16g CO₂ cartridge. The CO₂ cartridge 40 is threaded into aCO₂ port 41 on the module 18. As the closed end of the CO₂ cartridge 40is pierced, threading force will decrease. Threading should be continueduntil the connection is hand tight. Alternatively, connection of the CO₂cartridge 40 to the port 41 may not be done by threading and may be doneby other suitable mechanism, such as by press fit.

After the CO₂ cartridge is installed the pressure may be adjusted to adesired pressure, generally within the range of 0-80 psi, using thepressure adjustment knob 58. For example, the pressure may be adjustedto 40 psi. The power supply may be plugged into the module and connectedto power and the power switch may be toggled on. When the power isturned on, a light may be activated to show that power is on. Thethermal adjustment knob (54 in FIG. 4b ) may be used to adjust power tothe heating element as desired. The prime button (53 of FIG. 4b ) ispressed until a small amount of saline is dispensed from the nozzle. Atthis point, the device is ready for use.

Detail will now be given to use of the cleaning device system, inaccordance with one embodiment. In use, the camera, laparoscope, andlight source function as normal. Light from the laparoscope continues tofunction through the clear tip of the shaft. A default mode may be setfor pulsed CO₂.

The control pad may be used to activate cleaning. The buttons on thecontrol pad control use of the cleaning device. As described withrespect to FIG. 3a , these buttons may comprise, for example a cyclebutton 30, activating both irrigation and drying, and a drying button 32activating drying only. A single press of the clean cycle button resultsin a short burst of saline followed by a jet of CO₂ at the nozzle. Thedrying button may be programmed to operate in one of two modes: pulsedand continuous. In pulsed mode, a single press of the CO₂ button resultsin release of CO₂ in a programmed number of CO₂ bursts. In continuousmode, pressing the CO₂ button will directly control the duration of CO₂dispensing. To conserve CO₂ and prevent freezing of the CO₂ cylinder,the continuous dispense mode may be programmed with a limit on thedispense duration while holding the CO₂ button. Following a clean cycle,it may be desirable to leave a short period of time without cleaning forthe fluid to re-heat in the shaft. If CO₂ runs out during the procedure,the cartridge may be replaced by removing it from its location on themodule and replacing it. Similarly, if the reservoir empties during theprocedure, the reservoir may be refilled using the fill syringe.

The cleaning device may be programmed to customize the cycle and CO₂parameters. Specifically, variables controlling the clean cycle and theCO₂ cycle may be modified to achieve different system function such asshorter burst time, longer lockout delay, etc.

Clean cycle variables may include saline dispense time (e.g., 100milliseconds), delay between dispensing saline and CO₂ variable (e.g.,500 milliseconds), and CO₂ dispense time variable (e.g., 800milliseconds).

CO₂ variables may be based on whether the system runs in continuous CO₂mod or pulsed CO₂ mode. Variables in continuous CO₂ may include CO₂ runtime variable (e.g., 500 milliseconds) and system recovery time variable(e.g., 2000 milliseconds). Variables for pulsed CO₂ may include numberof pulses variable (e.g., 8) and pulse duration variable (e.g., 25milliseconds).

Various exemplary configurations of components of the cleaning devicesystem are shown in FIGS. 16a -20 g.

FIGS. 16a-16d illustrate a distal end of an extruded plastic sheath 14of a cleaning device and a nozzle 15 of a cleaning device, in accordancewith one embodiment. In this embodiment, the irrigation channel or lumen80 and the drying channel or lumen 82 are provided opposite one another.As shown, the irrigation channel 80 may comprise two irrigation channels80. One or heating channels 84 may be provided proximate the irrigationchannel 80. In an embodiment with two irrigation channels 80, theheating channel(s) 84 may be provided between the two irrigationchannels 80. The heating channel(s) 84 may receive resistive wire(s).

FIGS. 16a and 16b illustrate an extruded plastic sheath 14 having aninjection molded tip with a nozzle 15 attached to the shaft tip. FIG.16c illustrates an end view of the injection molded tip. In theembodiment shown, two irrigation channels 80 and a heating elementchannel 84 are provided on a first side of the sheath 14 and a dryingchannel 82, or CO₂ channel, is provided on a second side of the sheath14 opposite the first side of the sheath 14. Tip keys notches 85 areprovided in the sheath 14. FIG. 16d illustrates a rear view of a nozzle15 of a cleaning device, in accordance with on embodiment. As shown, thenozzle 15 includes tip keys 85 for engaging the tip key notches of thesheath 14. While tip keys and tip key notches are one manner of couplingthe nozzle 15 to the sheath 14, it is to be appreciated that anysuitable mechanism for coupling the nozzle 15 to the sheath 14 may beused. For example, the nozzle 15 may be press fit or threaded to thesheath 14.

FIGS. 17a-17d illustrate a distal end of a welded stainless steel sheath14 and a nozzle 15 of a cleaning device with a heating element 90layered into the sheath 14, in accordance with one embodiment. FIG. 17aillustrates a perspective view. FIG. 17b illustrates a cross sectionalview. FIG. 17c illustrates a cut away view of the sheath 14 only. FIG.17d illustrates a perspective view of the nozzle 15 only. The shaft maybe formed by laser cut, formed, and/or welded assembly. The tip may be amachined metal tip.

As shown in FIG. 17c , the shaft may have an outer wall 92 and an innerwall 94, with a heating element 90 provided between the outer wall 92and the inner wall 94 on one side of the sheath 14. The outer wall 92and inner wall 94 may be welded together at a weld point such as shownat 96.

FIGS. 18a-18f illustrate various aspects of a cleaning device 12 for usewith a laparoscope 5, in accordance with one embodiment. In theembodiment shown in FIGS. 18a -18 f, the retaining feature 20 isintegrated with the control pad 16. Shaft tube receptors 21 are shownand may include an irrigation tube receptor 21 a and a jet dry tubereceptor 21 b, for example. A strain relief element 102 may be providedat the cable/tubing exit. A membrane switch 100 may be provided on thecontrol pad retaining feature 16/20. A heating element port 104 andheating element channel 106 may be provided for receiving a heatingelement.

Attachment may done using connection of injection molded control padretaining feature 16/20 to an extruded sheath 14 via a lapped joint orextrusion 108. An open end of extrusion may closed with an adhesive plug110. The plug 110 provides strain relief on the heating element, forexample on heating element wires. In this embodiment, a two-buttonmembrane switch 100 is provided to control irrigation and jet-dryfunctionality. Single strain relief element 102 combines the irrigationtube, jet-dry tube, and electrical cable (switch and heating elementconductors). While this embodiment is specifically discussed withrespect to jet-drying, it is to be appreciated that it may also be usedwith vacuum drying.

FIGS. 19a-19c illustrate a lapped extrusion embodiment similar to thatof FIGS. 18a-18f but with the irrigation and drying channels 80, 82 onthe same side of the sheath 14, without a lip on the bottom edge of thenozzle, and with a lap joint 112 on connection of the nozzle 15 with thesheath 14.

FIGS. 20a-20d illustrate attachment of the sheath, in accordance withyet another embodiment. In the embodiment shown, attachment is doneusing connection of by providing injection molded components in thecontrol pad 16 and attaching such components to the shaft using flaredextrusion 114. In this embodiment, a two-button membrane switch isprovided to control irrigation and jet-dry functionality. Single strainrelief combines the irrigation tube, jet-dry tube, and electrical cable(switch and heating element conductors). While this embodiment isspecifically discussed with respect to jet-drying, it is to beappreciated that it may also be used with vacuum drying.

Various exemplary schematics and layouts of embodiments of the cleaningdevice system are shown in FIGS. 21a -27 b.

FIGS. 21a and 21b illustrate a schematic and layout for an embodiment ofa cleaning device using jet drying. As shown, the cleaning deviceincludes a battery, CO₂ cartridge, and fluid reservoir. These may beprovided in a module as described above. A power switch is provided fora user to actuate to turn on the battery and thus heat the heatingelement. The heating element may be, for example, a conformal resistiveshaft heater. The heater may be a heated coil tubing that combinestubing, heating element, and temperature sensing into one unit.

Two two-way valves are provided, actuated by button on the control pad.The two-way valves may be mechanical valves or solenoid valves. Thefirst button turns on the jet dry nozzle, the second button turns on theirrigation nozzle. Each of the irrigation and the jet dry are powered bythe CO₂ cartridge. The irrigation nozzle is fed fluid from the fluidreservoir.

FIGS. 22a and 22b illustrate an electrical control schematic and layoutfor an embodiment of a cleaning device using vacuum drying. In theembodiment shown, electronically controlled valves are used to enablecycle control. The fluid reservoir is relatively constantly pressurized.A downstream valve is provided and may be disposable.

FIGS. 23a and 23b illustrate a mechanical control schematic and layoutfor another embodiment of a cleaning device using vacuum drying. In theembodiment shown, mechanically controlled valves are used to operate thedevice. The fluid reservoir is relatively constantly pressurized. Adownstream valve is provided and may be disposable.

FIGS. 24a and 24b illustrate an electrical control schematic and layoutfor yet another embodiment of a cleaning device using vacuum drying. Inthe embodiment shown, electronically controlled valves are used toenable cycle control. The fluid reservoir is vented. An upstream valveis provided and may be reusable.

FIGS. 25a and 25b illustrate a mechanical control schematic and layoutfor a further embodiment of a cleaning device using vacuum drying. Inthe embodiment shown, mechanically controlled valves are used to operatethe device. The fluid reservoir is vented. An upstream valve is providedand may be reusable.

FIGS. 26a and 26b illustrate a schematic and layout for an embodiment ofa cleaning device using operating room supplied suction. In such anembodiment, no venturi valve, waste reservoir, or vent is used. The CO₂cartridge may have a reduced size compared to a CO₂ cartridge for acleaning device using suction but with suction being driven by the CO₂device. In the embodiment shown, electronically controlled valves areused and enable cycle control. The fluid reservoir is relativelyconstantly pressurized. A downstream valve is provided and may bedisposable.

FIGS. 27a and 27b illustrate a schematic and layout for a furtherembodiment of a cleaning device using operating room supplied suction.In such an embodiment, no venturi valve, waste reservoir, or vent isused. The CO₂ cartridge may have a reduced size compared to a CO₂cartridge for a cleaning device using suction but with suction beingdriven by the CO₂ device. In the embodiment shown, electronicallycontrolled valves are used and enable cycle control. The fluid reservoiris relatively constantly pressurized. A downstream valve is provided andmay be disposable.

FIGS. 28a and 28b illustrate a soiled scope and the soiled scope afteran initial wash at 5 psi irrigation and 40 psi jet-dry using a cleaningdevice as described herein. FIGS. 29a-29c illustrate a pre-soiled scope,a soiled scope, and a post cleaning scope wherein the soiled scope wascleaned using a cleaning device as described herein.

In general, the following parameters may be considered in selectingcombinations from the above options:

Nozzle geometry for irrigation channel;

Nozzle geometry for jet-dry channel;

Heating (power use, heater geometry, etc.);

Irrigation time for a cleaning cycle;

Jet-dry time for a cleaning cycle;

Liquid volume for a cleaning cycle; and

CO₂ volume for a cleaning cycle.

As used herein, the terms “substantially” or “generally” refer to thecomplete or nearly complete extent or degree of an action,characteristic, property, state, structure, item, or result. Forexample, an object that is “substantially” or “generally” enclosed wouldmean that the object is either completely enclosed or nearly completelyenclosed. The exact allowable degree of deviation from absolutecompleteness may in some cases depend on the specific context. However,generally speaking, the nearness of completion will be so as to havegenerally the same overall result as if absolute and total completionwere obtained. The use of “substantially” or “generally” is equallyapplicable when used in a negative connotation to refer to the completeor near complete lack of an action, characteristic, property, state,structure, item, or result. For example, an element, combination,embodiment, or composition that is “substantially free of” or “generallyfree of” an element may still actually contain such element as long asthere is generally no significant effect thereof

To aid the Patent Office and any readers of any patent issued on thisapplication in interpreting the claims appended hereto, applicants wishto note that they do not intend any of the appended claims or claimelements to invoke 35 U.S.C. § 112(f) unless the words “means for” or“step for” are explicitly used in the particular claim.

Additionally, as used herein, the phrase “at least one of [X] and [Y],”where X and Y are different components that may be included in anembodiment of the present disclosure, means that the embodiment couldinclude component X without component Y, the embodiment could includethe component Y without component X, or the embodiment could includeboth components X and Y. Similarly, when used with respect to three ormore components, such as “at least one of [X], [Y], and [Z],” the phrasemeans that the embodiment could include any one of the three or morecomponents, any combination or sub-combination of any of the components,or all of the components.

In the foregoing description various embodiments of the presentdisclosure have been presented for the purpose of illustration anddescription. They are not intended to be exhaustive or to limit theinvention to the precise form disclosed. Obvious modifications orvariations are possible in light of the above teachings. The variousembodiments were chosen and described to provide the best illustrationof the principals of the disclosure and their practical application, andto enable one of ordinary skill in the art to utilize the variousembodiments with various modifications as are suited to the particularuse contemplated. All such modifications and variations are within thescope of the present disclosure as determined by the appended claimswhen interpreted in accordance with the breadth they are fairly,legally, and equitably entitled.

What is claimed is:
 1. A cleaning device system for use with a surgicaldevice having a shaft and a lens at a distal end of the shaft, thecleaning device system comprising: a cleaning device comprising: asheath for fitting over the shaft of the surgical device, the sheathhaving an irrigation channel, a drying channel, and a heating channel,wherein the heating channel is disposed proximate the irrigationchannel; and a nozzle coupled to a distal end of the sheath, the nozzlehaving an irrigation port and a drying port, the irrigation channelterminating at the irrigation port and the drying channel terminating atthe drying port; and a module housing an irrigation fluid reservoir, agas canister, and a power source; wherein a first fluid is dispensedfrom the irrigation fluid reservoir in the module through the irrigationchannel in the sheath and out the irrigation port in the nozzle and asecond fluid is dispensed from the gas canister in the module throughthe drying channel in the shaft and out the drying port in the nozzle;and a control pad having a first button and a second button, wherein thefirst button runs a cleaning cycle including dispensing the first fluidand the second button runs a drying cycle including dispensing thesecond fluid.
 2. The cleaning device system of claim 1, wherein theirrigation fluid reservoir is refillable during a surgical procedure. 3.The cleaning device system of claim 1, wherein the gas canister isreplaceable during a surgical procedure.
 4. The cleaning device systemof claim 1, wherein the irrigation fluid reservoir has a volumesufficient for ten cleanings without refilling.
 5. The cleaning devicesystem of claim 1, wherein the irrigation port and the drying port areprovided on opposite sides of the nozzle.
 6. The cleaning device systemof claim 1, further comprising a second irrigation channel in the sheathand a second irrigation port in the nozzle, wherein the first and secondirrigation ports are provided on an opposite side of the nozzle from thedrying port, and wherein the heating channel is disposed between thefirst and second irrigation channels.
 7. The cleaning device system ofclaim 1, wherein the irrigation port and the drying port are provided ona same side of the nozzle.
 8. The cleaning device system of claim 1,wherein the cleaning cycle further comprises dispensing the secondfluid.
 9. The cleaning device system of claim 1, wherein the first fluidis saline and the second fluid is carbon dioxide gas.
 10. The cleaningdevice system of claim 1, wherein the nozzle is configured to direct thefirst fluid across the lens.
 11. The cleaning device system of claim 1,wherein the sheath and the nozzle are disposable.
 12. The cleaningdevice system of claim 1, further comprising an irrigation tube runningfrom the irrigation fluid reservoir to the irrigation channel and adrying tube running from the CO₂ canister to the drying tube.
 13. Thecleaning device system of claim 1, further comprising a heating elementdisposed in the heating channel.
 14. A cleaning device system for usewith a surgical device having a shaft and a lens at a distal end of theshaft, the cleaning device comprising: a cleaning device comprising: ashaft for fitting over the shaft of the surgical device, the shafthaving an irrigation channel and a drying channel; a nozzle coupled to adistal end of the shaft, the nozzle having an irrigation port and adrying port, the irrigation channel terminating at the irrigation portand the drying channel terminating at the drying port; and a modulehaving an irrigation fluid reservoir, a gas canister, and a powersource. wherein a first fluid is dispensed from the irrigation fluidreservoir in the module through the irrigation channel in the shaft andout the irrigation port in the nozzle and a second fluid is dispensedfrom the gas canister in the module through the drying channel in theshaft and out the drying port in the nozzle a non-tactile mechanism foractivating a cleaning cycle.
 15. The cleaning device system of claim 14,wherein the non-tactile mechanism is autonomous.
 16. The cleaning devicesystem of claim 15, wherein the autonomous mechanism for activating acleaning cycle is a sensor that senses when the lens is dirty byevaluating images from the lens.
 17. The cleaning device system of claim15, wherein the mechanism for activating a cleaning cycle is a sensorthat senses when the lens is dirty by evaluating light reflection. 18.The cleaning device system of claim 15, wherein the mechanism foractivating a cleaning cycle is voice activation.
 19. The cleaning devicesystem of claim 14, further comprising a heating channel in the sheath,wherein the heating channel is disposed proximate the irrigation channel20. A cleaning device system for use with a surgical device having ashaft and a lens at a distal end of the shaft, the cleaning devicesystem comprising: a cleaning device comprising: a sheath for fittingover the shaft of the surgical device, the sheath having an irrigationchannel, a drying channel, and a heating channel, wherein the heatingchannel is disposed proximate the irrigation channel; a nozzle coupledto a distal end of the sheath, the nozzle having an irrigation port anda drying port, the irrigation channel terminating at the irrigation portand the drying channel terminating at the drying port; and a modulehousing an irrigation fluid reservoir, a CO₂ canister, and a powersource, wherein the irrigation fluid reservoir has a volume sufficientfor at least ten cleanings without refilling; wherein saline isdispensed from the irrigation fluid reservoir in the module through theirrigation channel in the sheath and out the irrigation port in thenozzle and CO₂ gas is dispensed from the gas canister in the modulethrough the drying channel in the shaft and out the drying port in thenozzle; wherein the saline is heated to a temperature of at least 104°F. in the irrigation channel; and a control pad having a first buttonand a second button, wherein the first button runs a cleaning cyclecomprising dispensing the saline and dispensing the CO₂ and the secondbutton runs a supplemental drying cycle comprising dispensing the CO₂.